Description

Ciclesonide-D7 is a deuterated analog of the anti-inflammatory corticosteroid ciclesonide, specifically labeled with seven deuterium atoms. This stable isotope-labeled compound is a critical reference standard and internal standard for precise quantitative analysis in pharmaceutical research and development. It is essential for scientists and quality control professionals in the pharmaceutical and analytical chemistry industries who require high-fidelity tools for method development, pharmacokinetic studies, and ensuring batch-to-batch consistency of the active pharmaceutical ingredient.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for the identification and quantification of ciclesonide in drug substances and products.
• Mass Spectrometry Internal Standard: Used in LC-MS/MS and GC-MS bioanalytical methods for the accurate measurement of ciclesonide in complex biological matrices like plasma and tissue, enabling precise pharmacokinetic and metabolism studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Facilitates the study of absorption, distribution, metabolism, and excretion (ADME) profiles of the parent drug.
• Impurity Profiling and Method Development: Aids in the development and validation of sensitive analytical methods to detect and quantify related substances and degradants.
• Quality Control & Assurance: Employed in GMP environments to ensure the identity, potency, and purity of ciclesonide API and finished dosage forms through comparative analysis.
• Clinical Research: Supports bioequivalence studies and therapeutic drug monitoring programs requiring high analytical precision.

Basic Information

Product Name	Ciclesonide-D7
CAS No.	1225382-70-6
Molecular Formula	C32H37D7O7
Molecular Weight	~549.7 g/mol
Synonyms	16α,17-[(1R)-Cyclohexylmethylenebis(oxy)]-11β,21-dihydroxy-2'-deuterio-3',20-dioxopregna-1,4-dieno[16α,17-d]isoxazol-7α-d6-carbothioic Acid S-Fluoromethyl Ester; (11β,16α)-16,17-[[(1R)-Cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2H3)methoxy-3,20-dioxopregna-1,4-dieno[16,17-d][1,3]oxazole-7-carbothioic Acid S-((2H4)fluoromethyl) Ester; Deuterated Ciclesonide; Ciclesonide (D7)
EINECS	Contact for details

Quality Control

Our Ciclesonide-D7 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for analytical applications. Each batch is fully characterized using advanced techniques including NMR (¹H, ¹³C, ²H), High-Resolution Mass Spectrometry (HRMS), and HPLC. A comprehensive Certificate of Analysis (COA) is provided, detailing specifications for isotopic purity (atom % D), chemical purity, and confirming identity and potency. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Atom % D)	≥ 98.0% (by NMR or MS)
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.